Retinal photocoagulation, panretinal photocoagulation and intravitreal . endophotocoagulation of vascular and structural abnormalities of the retina and choroids, including:
- Proliferative and nonproliferative diabetic retinopathy
- Choroidal neovascularization
- Branch retinal vein occlusion
- The treatment of choroidal neovascularization associated with wet age related macular degeneration Retinal tears and detachments
- Retinopathy of prematurity
Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and open angle glaucoma

Intended for use in ophthalmic surgical procedures.

Device Description

The Photocoagulator Opto Mitra Yellow Laser is equipment capable of making human retinal photocoagulation by laser application at 586nm (yellow laser). The coagulation (clotting) of tissue using a laser which produces light in the visible yellow (586nm) wavelength that is selectively absorbed by hemoglobin, the pigment in red blood cells, in order to seal off bleeding blood vessels. Photocoagulation has diverse uses such as, for example, in cancer treatment to destroy blood vessels entering a tumor and depriving it from nutrients; in the treatment of a detached retina, to destroy abnormal blood vessels in the retina, to treat tumors in the eye, etc.

The equipment consists of three encoders which enable the physician to adjust the pulse duration, the laser power and the interval between successive pulses. All information is displayed on a color display 240x324 pixels TFT technology. On this display there is a touch-screen film responsible for the navigation software and by setting preferences, such as loudness, intensity laser sighting and display brightness.

Physicians have the option of applying single pulses or pulse trains previously adjusted. Power levels ranging from 50mW up to 2000MW, with resolution of 10mW. The duration can be set between 100ms and 3000 ms with a resolution of 10ms. The interval between pulses can be set between 100ms and 3000ms with 10ms resolution or can be set to single pulse (in this case, the range is set to zero).

The Opto Mitra Yellow Laser beam has a wavelength of 586nm, which is in the visible spectrum and is a yellow light. A red aiming beam is used to position the treatment Yellow beam prior to delivery.

The Opto Mitra Yellow Laser is a solid state, Optical Pumped Semiconductor surgical laser.

It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 586nm.

Compatible delivery devices include: slit lamp adapters/, laser indirect ophthalmoscopes (LIO) and endoprobe. All these accessories are specific for Opto Mitra Yellow Laser.

AI/ML Overview

The provided text describes a medical device, the Opto Mitra Yellow Laser, and its general performance standards and equivalency to predicate devices. However, it does not include the specific details required to answer the questions about acceptance criteria, a specific study proving it meets those criteria, sample sizes, ground truth establishment, or clinical performance metrics (like sensitivity, specificity, or MRMC study results).

The document is a 510(k) summary for the Opto Mitra Yellow Laser, which primarily focuses on demonstrating substantial equivalence to previously cleared devices. This type of submission typically relies on non-clinical performance data (bench testing) and comparison to predicate devices, rather than new clinical trials with detailed statistical analysis of human reader performance or ground truth establishment.

Here's why the requested information cannot be fully provided based on the input:

Acceptance Criteria & Reported Performance: The document provides technical specifications (e.g., wavelength, power, pulse duration, interval between pulses) as part of the device description, but these are not explicitly presented as "acceptance criteria" met by a study. Instead, they are characteristics of the device. There's no table comparing a predefined acceptance criterion to a measured performance value. The closest is the "Laser specification" on page 3, which lists the intended operating ranges and maximum errors, but these are design specifications, not study results against acceptance criteria.
Sample Size (Test Set), Data Provenance: Not mentioned.
Number of Experts, Qualifications, Adjudication Method: Not mentioned, as no human-in-the-loop clinical study is described.
MRMC Comparative Effectiveness Study: The document states that "Non-clinical performance data and conclusions from non-clinical tests Laboratory testing was conducted to validate and verify that the proposed device, Opto Mitra Yellow Laser meets all design specifications and is substantially equivalent to the predicate device." This indicates a reliance on bench testing and comparison to predicates, not a clinical trial with human readers. Therefore, no effect size of human improvement with AI is provided.
Standalone Performance: While the device itself is a standalone laser system, the concept of "standalone performance" in the context of diagnostic AI (sensitivity, specificity) does not apply here. The document states that "Laboratory testing was conducted to validate and verify that the proposed device, Opto Mitra Yellow Laser meets all design specifications and is substantially equivalent to the predicate device."
Type of Ground Truth: Not mentioned, as no clinical study with ground truth determination is described.
Sample Size (Training Set): Not applicable, as this is not an AI/ML diagnostic device that requires a training set in that sense.
Ground Truth for Training Set: Not applicable.

Based on the provided text, here is the information that can be extracted, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit clinical acceptance criteria (e.g., a specific success rate for photocoagulation) and corresponding clinical performance results from a study are not provided in the 510(k) summary, this table focuses on the technical specifications and performance characteristics mentioned for the device. The "Acceptance Criteria" here are interpreted as the stated design specifications or maximum allowable errors for the device's operational parameters.

Acceptance Criteria (Stated Design Specification)	Reported Device Performance (Implied from Design)
Laser:
Wavelength: 586nm (± 3nm)	586nm (± 3nm)
Max Output Power: 2000mW	Max 2000mW
Power Resolution: 10mW	10mW
Max Error (Power): ± 20%	Implied to meet ± 20%
Aiming Laser:
Wavelength: 635nm (± 20nm)	635nm (± 20nm)
Max Output: 0.7mW (± 0.2mW)	0.7mW (± 0.2mW)
Pulse Duration:
Range: 10ms to 1000ms	10ms to 1000ms
Max Error: 10%	Implied to meet 10%
Interval between Pulses:
Range: 50ms to 3000ms	50ms to 3000ms
Max Error: 10%	Implied to meet 10%
Single pulse option	Available
FastPulse Configuration:
Period: 1800 us to 2200 us (± 100 us)	Meets 1800 us to 2200 us (± 100 us)
Duty-Cycle: 5% to 15% (± 1%)	Meets 5% to 15% (± 1%)
Safety and Standards:
Compliance with IEC 60825-1:2007	Compliant
Compliance with IEC 60601-2-22:1995	Compliant
Compliance with IEC 60601-1:1988+A1:1991+A2:1995	Compliant
Compliance with IEC 60601-1-2:2001	Compliant
Compliance with IEC 60601-1-4:2000	Compliant
Compliance with European Medical Directive 93/42/EEC & 2007/47/EEC	Compliant
Compliance with US Federal Standards 21 CFR 1002.10 Req. (CFR 1040.10, 1040.11), 1010.2, 1010.3	Compliant
Compliance with Part 820 - Quality System Req.	Compliant
ISO 9001 and 13485 System Certification	Certified
Compliance with IEC 62304:2006	Compliant

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not mentioned. The document primarily refers to "non-clinical performance data and conclusions from non-clinical tests (Laboratory testing)" to validate design specifications. No clinical test set involving human subjects is described.
Data Provenance: Not applicable for a clinical test set, as none is described. Laboratory testing would be conducted internally by the manufacturer, Opto Eletrônica S/A (Brazil).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical test set requiring expert ground truth establishment is described.

4. Adjudication method for the test set:

Not applicable, as no clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. The device is a medical laser system, not an AI diagnostic tool.
Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself, the Opto Mitra Yellow Laser, is a standalone medical device. The "standalone performance" mentioned in the document refers to its technical specifications and compliance with safety standards as verified through laboratory testing.
The document states: "Laboratory testing was conducted to validate and verify that the proposed device, Opto Mitra Yellow Laser meets all design specifications and is substantially equivalent to the predicate device." This refers to non-clinical, bench-top testing of the device's technical performance parameters (e.g., power output, wavelength accuracy, pulse duration).

7. The type of ground truth used:

Ground truth in the traditional sense (e.g., pathology, clinical outcome, expert consensus for diagnosis) is not explicitly discussed as part of a performance study for this device type. For a laser device, "ground truth" during development and testing likely refers to engineering specifications and performance benchmarks (e.g., a power meter as "ground truth" for laser output power, a spectrometer for "ground truth" on wavelength).

8. The sample size for the training set:

Not applicable, as this is not an AI/ML diagnostic device with a "training set" in that context.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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K111643

Image /page/0/Picture/2 description: The image shows the word "opto" in a bold, sans-serif font. Below the word "opto" is the tagline "Science in Sight" in a smaller, italicized font. The word "opto" is the main focus of the image, with the tagline providing additional context.

Executive Summary

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

1. Submitter Information

Submitter: Opto Eletrônica S/A

Address: NO. 1071 - Joaquim Augusto Ribeiro de Souza street- Jardim Santa Felícia - São Carlos - SP/ Brazil

Phone: + 55 (16) 2106-7029

Contact name: Paulo Aneas Lichti

Prepared on: 03/23/2011

Registration number: 9613205

2. U.S. Agent to respond to FDA requests:

Establishment: Opto Usa Corporation

Contact Person: Paulo Aneas Lichti

Address: 12550 BISCAYNE BLVD, 605, MIAMI - FL - 33181

Phone: 1 305 981 2979 - Fax: 1 305 981 2980

3. Device Classification Name

Device Name: Opto Mitra Yellow Laser

Common name: Ophthalmic Laser, Surgical Laser

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K11643

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Science in Sight

Classification name:

HQF, Laser, Ophthalmic

GEX, Powered Laser Surgical Instrument

Regulation Number:

21 CFR 886.4390, Ophthalmic Laser

21 CFR 878.4810, Surgical Devices

Regulatory Class:

Class II

Performance standards:

21 CFR 1040.10

Predicate Device Name: 4.

Iridex IQ 577, Iridex Corporation, K071687

Nidek Multicolor Laser Photocoagulator System MC-500, K110228

Product Description 5.

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K111643

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treatment of a detached retina, to destroy abnormal blood vessels in the retina, to treat tumors in the eye, etc.

Indicated for Use 6.

Indicated for use in photocoagulation of both anterior and posterior segments, including:

Retinal photocoagulation, panretinal photocoagulation and intravitreal . endophotocoagulation of vascular and structural abnormalities of the retina and choroids, including:
- イ Proliferative and nonproliferative diabetic retinopathy
- イ Choroidal neovascularization
- V Branch retinal vein occlusion
- イ The treatment of choroidal neovascularization associated with wet age related macular degeneration Retinal tears and detachments
- V Retinopathy of prematurity

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Science in Sight

. Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and open angle glaucoma

Intended Use 7.

Intended for use in ophthalmic surgical procedures.

8. Target Population

Individuals of all ages with diabetic retinopathy, glaucoma, or who have suffered any trauma causing a retinal detachment. Premature child with symptoms of prematurity retinopathy.

Technical Characteristics 9.

The Opto Mitra Yellow Laser beam has a wavelength of 586nm, which is in the visible spectrum and is a yellow light. A red aiming beam is used to position the treatment Yellow beam prior to delivery.

The Opto Mitra Yellow Laser is a solid state, Optical Pumped Semiconductor surgical laser.

It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 586nm.

Compatible delivery devices include: slit lamp adapters/, laser indirect ophthalmoscopes (LIO) and endoprobe. All these accessories are specific for Opto Mitra Yellow Laser.

Laser specification: .

.. .

o Laser of 586nm (± 3nm), with a maximum output of 2000mW, resolution of 10mW and maximum Error of ± 20% in relation to the power set;
o Laser Aim of 635nm (± 20nm), with a maximum output of 0.7mW (± 0.2mW);

Sec: 05 - page 4 of 7

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KIII1643

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Science in Sight

Pulse Duration: .

o From 10ms to 1000ms with a maximum Error of 10%.

Interval between Pulses: .

o From 50ms to 3000ms with a maximum Error of 10%.
o The single pulse can be used This option enables activating a single pulse with a pre-selected duration.

Operating range in the FastPulse configuration: .

o FastPulse Period: from 1800 us to 2200 us (± 100 us);
o Duty-Cycle of the FastPulse : from 5% to 15% (± 1%) of the period chosen ( time "on" );

Operational Characteristics: .

o Autoprograming according to the type of accessory coupled to the Opto Mitra Yellow Laser, through the Autokey;
o Aiming Beam and Power Laser Divergence: single optical path, with coupling of the beams set at 100% of the units produced;
o Automatic mode selection according to the accessory used, through the AutoKev:
o Accessories such as Endoprobes, Slit Lamp Adapter and Ophthalmoscopes are connected to the main unit through the "optical fiber" opening, which is an optical-mechanical connector;
o Emergency Key;
TFT Color Display with 32000 colors; o
o Touchscreen Activation of commands by simply touching the display;

...

o Control buttons without final stroke and with back lighting.

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10. Accessories

Eye Safety Filter
Pedal Multifunctional .
Slit Lamp Adapter .

11. Compatible Delivery Devices

Ophthalmoscope .
Probe .

12. Performance Standard

Opto Mitra Yellow Laser is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including:

IEC 60825-1:2007, Safety of laser products - Part I : Equipment ● classification, requirements and user's quide.
IEC 60601-2-22: Ed 1995, Medical electrical Equipment Part 2 : ● Particular requirements for the safety of diagnostic and therapeutic laser equipment.
IEC 60601-1: 1988 + AI: 1991 + A2:1995, Medical Electrical equipment . -Part I : general requirement for safety.
IEC 60601-1-2: 200 1, Medical Electrical equipment -Part I : General . safety-2, Collateral requirements for Standard : electromagnetic compatibility - requirements and tests.
IEC 6060 1-1-4: 2000, Medical electrical equipment Part I : General . requirements for safety -4 - Collateral standard : Programmable electrical medical systems, edition 1.1.
The device also complies with European Medical Directive 93/42/EEC . 2007/47/EEC and the Performance ਜ Amendment US Federal Standards 21 CFR 1002. 10 Requirements (21 CFR 1040. 10 and 21 CFR 1040.11 for Class IV Laser). Part 1010.2 and 1010.3,Part 820 - Quality System Requlation, and has passed ISO 9001 and 13485 System Certification.
IEC 62304:2006, medical device software Software life cycle processes .

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111643

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Science in Sight

Discussion of similarities and Differences from the Predicate Product 13.

Opto Mitra Yellow Laser shares the same indications for use and safety compliance, similar design features, functional features, and therefore are substantially equivalent to the predicate device , K071687 and K110228 . In addition, a review of the predicate device shows that the Opto Mitra Yellow Laser is safe and effective as the predicate device as they share equivalent specifications / characteristics and are used to perform the same indicated surgical procedures.

The only difference in the specifications/characteristics of the Opto Mitra Yellow Laser and its predicate K071687 is as follows:

1. Opto Mitra Yellow Laser has a wavelength of 586nm and 577nm for IQ 577. This difference is not viewed as being clinically significant.

Conclusion:

Opto Mitra Yellow Laser uses the same fundamental technology features as the IQ 577 and delivers the same level of effectiveness. Therefore, the conclusion that there is no significant difference in the basic function, safety and effectiveness between the K071687 and K110228 (Predicate Device) and the Opto Mitra Yellow Laser.

The Opto Mitra Yellow Laser is substantially equivalent to predicate devices currently legally marketed for treatments in ophthalmology.

Non-clinical performance data and conclusions from non-clinical tests Laboratory testing was conducted to validate and verify that the proposed device, Opto Mitra Yellow Laser meets all design specifications and ાંડ substantially equivalent to the predicate device.

15. Conclusion

Based on the information in this notification we conclude that Opto Mitra Yellow Laser is substantially equivalent to predicate devices currently legally marketed for the indication of retinal photocoagulation laser. Only applicable for use in ophthalmology.

The Opto Mitra Yellow Laser shares the same intended use, indications for use, and similar technical characteristics to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

NOV - 3 2011

Opto Eletronica S/A % Mr. Paulo Aneas Lichti Joaquim A.R. de Souza Street 1071 - Jardim Santa Felicia Sao Carlos, San Paulo Brazil 13563-330

Re: K111643

Trade/Device Name: Opto Mitra Yellow Laser Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HOF Dated: October 21, 2011 Received: October 24, 2011

Dear Mr. Lichti:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Paulo Aneas Lichti

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if know): K111643

Device Name: Opto Mitra Yellow Laser

The Opto Mitra Yellow Laser is indicated for retinal photocoagulation. Used for the following ophthalmic medical condition end treatment:

Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroids, including:
- く Proliferative and nonproliferative diabetic retinopathy
- イ Choroidal neovascularization
- イ Branch retinal vein occlusion
- く The treatment of choroidal neovascularization associated with wet age related macular degeneration Retinal tears and detachments
- イ Retinopathy of prematurity
lridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and open . angle glaucoma

Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVE

Neil R. Ogle Forman
(Division Sign Off)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number	K 111 643
	Sec: 04 Page 1 of 1

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.